PROSPECT: Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial
This trial is key in the ongoing search for more effective strategies to prevent serious infection during critical illness in the elderly. Probiotics may be an easy‐to‐use, readily available, inexpensive approach to help reduce infections in older critically ill patients around the world.
Possible Research Results
Anticipated impact of findings: PROSPECT will determine whether a low cost, readily available intervention - probiotics - have any effect reducting the risk of infection in frail critically ill persons. Frailty is an important construct that will be increasingly measured in intensive care unit (ICU) patients, including in the PROSPECT Trial. In the context of critical illness, degree of frailty identifies a vulnerable population at risk for worse outcomes such as rehospitalization and one-year mortality. There is growing interest in screening for frailty in various healthcare settings. Little is known about the reliability of the Clinical Frailty Score (CFS) in the ICU setting. Associated with the PROSPECT Trial, there will be a stand-alone audit which will help to address that gap by characterizing pre-ICU frailty in consecutive heterogeneous patients in two ICUs using the CFS, comparing assessments without and with family input and between a Research Coordinator, Occupational Therapist and the patient.
About the Project
According to the World Health Organization, probiotics are commercially available live bacteria thought to have health benefits when ingested. Our literature review of probiotic studies in the ICU found that patients who receive probiotics experience a 25% reduction in lung infection, known as ventilator‐associated pneumonia (VAP). There is also an 18% reduction in the chance of developing any infection in the ICU. Although probiotics also seem to reduce antibiotic associated diarrhea and Clostridium difficile bowel infections in other settings, this has not been properly evaluated in the ICU, and elderly patients are often excluded from trials in this setting.
VAP is an infection that is associated with morbidity, mortality and substantial cost. Older patients are at particularly high risk for VAP, likely due to their aging immune system. Probiotics are promising in terms of effectiveness and cost‐effectiveness for preventing VAP, but studies in critically ill patients have not been well done.
Therefore, whether probiotics can really prevent VAP and other infections is unclear. We completed a pilot study in 14 ICUs in Canada and the United States which showed that a larger trial was feasible. Specifically, we enrolled the target number of patients, of which 40% were ≥65 years of age; we followed the protocol faithfully, made sure patients didn't receive additional probiotics and estimated how many patients developed pneumonia.
We are now ready to establish the effects of probiotics in the ICU in a large trial. In critically ill patients who need support by a breathing machine, we will investigate whether oral L. rhamnosus GG (a common probiotic) prevents VAP and other infections. Following informed consent, patients will be randomized to either L. rhamnosus GG group or an identical placebo twice daily, down a feeding tube. We will record VAP, other serious infections such as Clostridium difficile, and overutilization of antibiotics.
For more details on the project rationale, objective and research plan, click here.
Deborah Cook, MD, MSc (Epid), FRCPC, DABIM, CCM, CAHS, FRS -- McMaster University
Ian Ball, MD -- Western University
Emmanuel Charbonney, MD -- Université de Montréal
Laurence Chau, MD -- Oakville Trafalger Hospital
Robert Cirone, MD -- St. Joseph's Health Centre
Peter Dodek, MD -- University of British Columbia
Martin Girard, MD -- Université de Montréal
Eyal Golan, MD -- University of Toronto
Rick Hall, MD -- Dalhousie University
William Henderson, MD -- University of British Columbia
Margaret Herridge, MD -- University of Toronto
Jennie Johnstone, MD -- Dalla Lana School of Public Health, University of Toronto/Public Health Ontario
Tim Karachi, MD -- McMaster University
Kosar Khwaja, MD -- McGill University
Arnie Kristof, MD -- McGill University
Jim Kutsiogianis, MD -- University of Alberta
François Lamontagne, MD -- Université de Sherbrooke
François Lauzier, MD -- Université Laval
John Marshall, MD -- University of Toronto
Lauralyn McIntyre, MD -- University of Ottawa
Maureen Meade, MD -- McGill University
Sangeeta Mehta, MD -- University of Toronto
Andrew Morris, MD -- University of Toronto
Daniel Ovakim, MD -- University of British Columbia
Joe Pagliarello, MD -- University of Ottawa
Brenda Reeve, MD -- Brantford General Hospital
Bram Rochwerg, MD -- McMaster University
Lehana Thabane, PhD -- McMaster University
Gordon Wood, MD -- University of British Columbia
Ryan Zarychanski, MD -- University of Manitoba/CancerCare Manitoba
Project Contact: Dr. Deborah Cook -- firstname.lastname@example.org
Key words: critically ill; probiotics; systematic review